update the benefit-risk determination and to improve the risk management. The purpose of the PSUR is to track the conclusions of the benefit-risk determination, the main findings of the Post-Market Clinical Follow-Up (PMCF) and the volume of sales throughout the lifetime of the device concerned. For example, ISO13485:2016 mentions PMS activities in Section 8.2.1 regarding feedback processes which should include provision to gather data from production, as well as post-production activities and 8.5.1 improvement actions from QMS sections including PMS. Ensuring your Post-Market Surveillance Process Meets the New ISO 14971:2019 Guidance and MDR/IVDR Requirements Learn More. Webinar. MDR IVDR Post-market surveillance system MDR Article 83: Post-market surveillance system of the manufacturer MDR Article 15: Person responsible for regulatory compliance Comprehensive system to gather experience from the use of devices Proactive and systematic Allows cooperation on vigilance and market surveillance Post Market Surveillance System Article 10, 10. lays down the requirement for all Manufacturers to have a Post Market Surveillance (PMS) System. Your post-market surveillance will tell the whole story about how well your plan was executed. According to Article 78, the PMS system involves at least eight, possibly nine, different processes. Post-Market Surveillance Requirements Guide to Manufacturers Law.eu MDR/IVDR IMPLEMENTATION TOOLS JANUARY 2019 Any reproduction or further dissemination of this publication is not allowed, unless prior written approval is provided by the Content Manager of MDlaw.eu (contact: [email protected]). The PMS report is part of the Technical Documentation on Post Market Surveillance (Annex III, 2.). and in Annex III. Ivdr Post Market Surveillance Plan Template On July 16, 2020 By Balmoon Mdcg 2019 15 mdcg 2020 1 eu medical device mdr 2017 745 and in to the regulation of medical devices Last Name. Company. Post-Market Surveillance Requirements Guide to Manufacturers Law.eu MDR/IVDR IMPLEMENTATION TOOLS JANUARY 2019 Any reproduction or further dissemination of this publication is not allowed, unless prior written approval is provided by the Content Manager of MDlaw.eu (contact: [email protected]). Previously, NAMSA’s blog series discussed the QMS application under the IVDR. PMS processes should then inform the Performance Evaluation Report (PER) that is part of the technical documentation. This is shown by Articles 57 et seqq. © North American Science Associates, Inc. 2021. What Type of Data Comprises PMS Data? Post-market surveillance aims to ensure that IVDs continue to meet the same quality, safety and performance requirements as when they were initially placed on the market. • Post-market surveillance: • Overview • Interpret regulatory requirements for post-market surveillance and vigilance under the MDR and IVDR • Why is Post-Market Surveillance (PMS) necessary? Post-Market Surveillance, Market Surveillance & Vigilance. … TABLE OF CONTENTS. The IVDR pays particular interest to information regarding incidents (serious and non-serious), undesirable effects, field safety notices, information from trend reporting, literature database searches, feedback from multiple areas (complaints from users, distributors and importers) and public information from similar devices. First Name. The feedback information required by each process is different: The risk management process requires information about the frequency and severity of harm which results from using the device, manufacturing requires information about nonconformities, the clinical evaluation requires information on clinical performance and so on. BSI’s ‘Post-market Surveillance and Vigilance under the Medical Device Regulation (MDR) and In Vitro Diagnostics Medical Devices Regulation (IVDR)’ one-day training course has been designed to provide manufacturers with the tools to implement an appropriate system for gaining and reviewing experience in the post production phase from the range of devices they manufacture. These are intended to confirm that devices on the market do not endanger health, safety or any other aspect of public interest. Don’t miss our e-Learning on IVDR implementation strategies.In a series of 9 sessions we will help you to understand how the new IVDR will affect your product.Within this e-Learning you will learn what the new requirements for post-market surveillance (PMS) and vigilance are under the IVDR and what the new requirements on trend reporting and post-market performance follow-up Download this free excerpt from Compliance Navigator's Smart Support series of expert commentaries on the MDR/IVDR for: Insight into the background to the changes to EU post-market … Visit NAMSA Client Portal for sample submissions, testing reports, project tracking, and more. Don’t miss our e-Learning on IVDR implementation strategies.In a series of 9 sessions we will help you to understand how the new IVDR will affect your product.Within this e-Learning you will learn what the new requirements for post-market surveillance (PMS) and vigilance are under the IVDR and what the new requirements on trend reporting and post-market performance follow-up Too add to the complexity, generally speaking, the required feedback information isn’t available in the format that the processes need. Post Market Surveillance (PMS) is primarily concerned with establishing the PMS plan for the device. At this point it’s also worth reflecting on the purpose. PMS programs should actively and systematically gather information from a device in a way which allows for regular updates to technical documentation and competent authorities’ communication in the areas of vigilance and market surveillance. The Person Responsible for Regulatory Compliance (PRRC) is, under the MDR and the IVDR, a person responsible for ensuring compliance with the MDR/IVDR requirements regarding the conformity of the devices, the technical documentation, the EU declaration of conformity, the post-market surveillance obligations and the reporting of serious incidents and field safety corrective … Gain insight into post-market surveillance for medical devices and in vitro diagnostic devices under the EU Regulations with this free download. PMS programs should actively and systematically gather information from a device in a way which allows for regular updates to technical documentation and competent authorities’ communication in the areas of vigilance and market surveillance. 2 Background to changes The Medical Devices Regulation (MDR) (Regulation (EU) 2017/745) and In Vitro Medical Device Regulation (IVDR) (Regulation (EU) 2017/746) are significant changes to European legislation for medical devices. Warren Jameson is a Sr. Regulatory Consultant-IVD at NAMSA. To begin, it is important to understand how PMS is defined under the IVDR: “‘all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.” Annex 2 (63). EU IVDR. A good post-market surveillance (PMS) system is composed by two different parts: Post-Market Clinical Follow-up Conformity assessment: “Conformity assessment, conducted before and after a medical device is placed on the market, and post-market surveillance of devices in actual use are complementary elements of the GHTF global regulatory model. 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